Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pin, Fixation, Smooth
510(k) Number K092038
Device Name APTUS K-WIRE SYSTEM
Applicant
Medartis AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact KEVIN THOMAS
Correspondent
Medartis AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact KEVIN THOMAS
Regulation Number888.3040
Classification Product Code
HTY  
Date Received07/06/2009
Decision Date 09/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-